Senior Biostatistician

Summary: The Senior Biostatistician role involves leading the statistical aspects of clinical studies, from design to reporting, while ensuring compliance with industry standards. The position requires extensive experience in statistical programming and mentoring junior team members. Strong communication and leadership skills are essential for cross-functional collaboration. This is a long-term remote contract position based in the USA, specifically for candidates in the EST time zone.

Key Responsibilities:

• Lead statistical aspects of clinical studies from design to final reporting
• Review and approve programming deliverables (ADaM datasets, tables, listings, and figures)
• Mentor junior biostatisticians and support team development
• Ensure compliance with industry standards (CDISC, ICH, FDA/EMA guidelines)
• Draft SAP/shell independently
• Work in detail and able to review the TLF
• Excellent communication and leadership skills with cross-functional collaboration experience

Key Skills:

• At least 6-8 years of experience in biostatistics
• Statistical Programming II experience
• Proven expertise in SAS and/or R for statistical analysis
• Strong communication and leadership skills
• Experience with cross-functional collaboration

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: Senior

Industry: Other